Welch Allyn MacroView Manual

Digital MacroView™ Otoscope
Directions for use

ii
© 2014 Welch Allyn. All rights are reserved. No one is permitted to reproduce or
duplicate, in any form, this manual or any part thereof without permission from
Welch Allyn.
Caution: Federal law restricts this device to sale by or on the order of a licensed
professional trained in otoscopy.
Welch Allyn assumes no responsibility for any injury, or for any illegal or improper
use of the product, that may result from failure to use this product in accordance
with the instructions, cautions, warnings, or indications for use published in this
manual.
Welch Allyn is a registered trademark of Welch Allyn, Inc. Digital Macroview is a
trademark of Welch Allyn, Inc.
Software in this product is copyright Welch Allyn or its vendors. All rights are
reserved. The software is protected by United States of America copyright laws
and international treaty provisions applicable worldwide. Under such laws, the
licensee is entitled to use the copy of the software incorporated with this
instrument as intended in the operation of the product in which it is embedded.
The software may not be copied, decompiled, reverse-engineered, disassembled
or otherwise reduced to human-perceivable form. This is not a sale of the
software or any copy of the software; all right, title, and ownership of the
software remain with Welch Allyn or its vendors.
For patent information, please visit www.welchallyn.com/patents.
For information about any Welch Allyn product, contact your local Welch Allyn
representative: www.welchallyn.com/about/company/locations.htm.
DIR 80019712 Ver A
This manual applies to 901021 Otoscope, Wideview
Changes or modifications not expressly approved by Welch Allyn could
void the purchaser’s authority to operate the equipment.
Welch Allyn, Inc.
4341 State Street Road,
PO Box 220
Skaneateles Falls, NY 13153
USA
www.welchallyn.com
European Regulatory Manager
Welch Allyn Ltd.
Navan Business Park
Dublin Road
Navan, County Meath,
Republic of Ireland
EC REP

iii
Contents
1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
System Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
User Profile. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Warnings and cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Using the otoscope head . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Using the Digital MacroView system . . . . . . . . . . . . . . . . . . 8
Using focus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Using the controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Reviewing images . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Standby Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Using the throat illuminator . . . . . . . . . . . . . . . . . . . . . . . . 13
3 Maintenance and service. . . . . . . . . . . . . . . . . 15
Replacing the lamp. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Cleaning recommendation . . . . . . . . . . . . . . . . . . . . . . . . . 17
Recycling the system components . . . . . . . . . . . . . . . . . . 18
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Service policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
4 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . 23

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1
1
Introduction
The Digital MacroView System consists of a digital otoscope
head and a USB Video Cable. A 3.5 volt Welch Allyn power
source and a computer are necessary to use the Digital
MacroView System.
Current available Digital MacroView versions:
• 23920 Digital MacroView for medical
• 23960 Digital MacroView for veterinarian
The Digital MacroView System is designed for “Plug and Play”
operation - all adjustments including illumination and white
balance are pre-set at the factory.
System Requirements
The Digital MacroView requires a user device running Windows
XP Service Pack 2 or later operating system, a viewing screen,
and a USB 2.0 port.
Intended use
The otoscope is intended to allow inspection of the external ear,
ear canal, and tympanic membrane under magnification. A
secondary use of the otoscope may be for assessing the
flexibility of the tympanic membrane (pneumatic otoscopy).
User Profile
The Digital MacroView is intended for licensed professionals
trained in otoscopy.

2Introduction Welch Allyn
Symbols
Safety symbols
Button symbols
WARNING Caution
Consult operating
instructions/directions for
use (DFU). A copy of the
DFU is available on this
website. A printed copy of
the DFU can be ordered
from Welch Allyn for
delivery within 7 calendar
days.
IPXO Not protected from the
ingress of water
Product identifier Reorder number
Type BF applied part Temperature limit
USB Humidity limitation
Recycle the product separate from other disposables. See
“Recycling the system components” on page 18.
Capture Image
Zoom

Directions for use Digital MacroView 3
Agency certifications
CERTIFIED TO:
CAN/CSA STD C22.2 NO. 601.1
CONFORMS TO:
UL STD 60601-1
IEC 60601-1
The CE mark on this product indicates that it has been tested
to and conforms with the provisions noted within the 93/42/
EEC Medical Device Directive.
European Regulatory Manager
Welch Allyn Ltd.
Navan Business Park • Dublin Road • Navan, County Meath,
Republic of Ireland
EC REP

4Introduction Welch Allyn
Warnings and cautions
Familiarize all operating personnel with the general safety
information in this summary. Specific warnings and cautions are
also found throughout this manual. Such specific warnings and
cautions may not appear here in this summary.
Warnings
A warning statement in this manual identifies a condition or
practice, which if not corrected or discontinued immediately,
could lead to injury, illness, or death.
Cautions
A caution statement in this manual identifies a condition or
practice, which if not corrected or discontinued immediately,
could lead to equipment failure, equipment damage, or data loss.
WARNING No modification of the equipment is
allowed.
WARNING Do not use in the presence of flammable
anesthetics.
WARNING This product has no user serviceable/
replaceable parts except for the lamp. Please refer all
other service to authorized service personnel.
WARNING This instrument is not intended to be used
in the eye.
WARNING This product generates and records
reference images from inputs obtained from the Welch
Allyn Digital Macroview. These reference images are not
intended for diagnostic purposes.

Directions for use Digital MacroView 5
Caution In order to obtain optimum performance and
ensure patient safety, thoroughly read this booklet.
Caution The Digital MacroView System is designed
expressly for use with an approved Welch Allyn 3.5v
power source. Damage to the system will occur if
alternate power sources are attached to the video head.
Caution Do not use the Digital MacroView if you
notice any signs of damage to the components of the
system. Contact Customer Service Department for
immediate assistance.
Caution Before each use, the outer surface of the ear
specula on the Digital MacroView which is intended to
be inserted into a PATIENT should be checked to ensure
there are no unintended rough surfaces, sharp edges or
protrusions which may Cause a SAFETY HAZARD.
Caution Do not attempt to disinfect the Digital
MacroView System using glutaraldehyde products,
ethylene oxide gas, steam or any other liquid or gas
disinfectant.
Caution The signal output (USB Port) connector is
intended for connection of only devices complying with
IEC 60601-1, or other IEC standards (for example, IEC
60950), as appropriate to the device. Connecting
additional devices to the Digital MacroView System is
configuring a medical system and you are responsible
for verifying that the system complies with the
requirements of the system standard IEC 60601-1-1
Caution This product complies with current required
standards for electromagnetic interference and should
not present problems to other equipment or be affected
by other devices. As a precaution, avoid using this
device in close proximity to other equipment.

6Introduction Welch Allyn
Caution To minimize external otoscope housing
temperatures, on-time should not exceed 2 minutes and
off-time a minimum of 10 minutes.
Caution Only accepts Welch Allyn specula.
Caution Use only Welch Allyn approved lamps.
Caution Do not apply alcohol, chemicals, or water to
the lenses. Solution entering the optical assembly could
damage internal components.